Arimoclomol Pregnancy and Breastfeeding Warnings

Brand names: Miplyffa

Medically reviewed by Drugs.com. Last updated on Oct 7, 2024.

Arimoclomol Pregnancy Warnings

Safety has not been established during pregnancy.

US FDA pregnancy category: Not assigned

Risk summary: Based on animal data, this drug may cause embryofetal harm when administered to a pregnant patient; no data are available on the use of this drug in pregnant patients to inform a drug-related risk.

Comments:
-If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential harm to the fetus.
-Pregnancy planning and prevention should be considered for patients of childbearing potential.

Animal studies have revealed evidence of embryofetal harm, including teratogenicity and embryofetal lethality. After once-daily oral dosing in pregnant rats during organogenesis, increased postimplantation loss was seen at 10-fold the human exposure, based on AUC at the maximum recommended human daily dose (MRHDD) of 372 mg, as well as increased ossification in the vertebrae and dilated brain ventricles in litters of dams administered doses at least 8-fold the human exposure at the MRHDD. After thrice-daily dosing in pregnant rats during organogenesis, increased postimplantation loss and reduced maternal, placental, and fetal weights were observed at 14-fold the human exposure, based on AUC at the maximum recommended human dose (MRHD); additionally at this exposure level, fetuses showed various structural abnormalities. After once-daily oral dosing in pregnant rabbits during organogenesis, increased incidences of minor skeletal variations were seen at 5-fold the human AUC at the MRHDD, coinciding with an adverse decrease of maternal body weight. After pre- and postnatal oral dosing in rats, increased embryofetal lethality and reduced pup weight (with slightly decreased maternal body weight gain) were seen at 10-fold the human AUC at the MRHDD. There are no controlled data in human pregnancy.

Based on animal data, this drug may impair fertility in females and males of reproductive potential. Oral dosing in rats lead to reduced male and female fertility at 9-fold and increased preimplantation loss at 5-fold the human exposure, based on AUC at MRHD; it is not known if these effects are reversible.

US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.

See references

Arimoclomol Breastfeeding Warnings

The manufacturer makes no recommendation regarding use during lactation.

Excreted into human milk: Unknown
Excreted into animal milk: Unknown

Comments:
-Developmental and health benefits of breastfeeding should be considered as well as the mother's clinical need for this drug.
-The effects in the nursing infant are unknown; potential adverse effects in the breastfed child due to this drug or the mother's underlying condition should be considered.

See references

Further information

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